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脆弱なアテローム性動脈硬化性冠動脈プラークに対する予防的PCIまたは薬物療法のみ
基本情報
- NCT ID
- NCT02316886
- ステータス
- 完了
- 試験のフェーズ
- 第4相
- 試験タイプ
- 介入
- 目標被験者数
- 1,608
- 治験依頼者名
- Asan Medical Center
概要
The primary aim of the trial is to determine whether preventive PCI with bioabsorbable vascular scaffolds (BVS) (early period) or everolimus-eluting stents (middle and late period) plus optimal medical therapy (OMT) on functionally insignificant (FFR \> 0.80) vulnerable coronary plaque, as determined by intracoronary imaging, would result in a significant reduction of the primary composite outcome of death from cardiac causes, target-vessel myocardial infarction (MI), target-vessel revascularization (TVR), and hospitalization for unstable or progressive angina at 2 years, when compared with OMT alone.
対象疾患
Coronary Artery DiseasePlaque, Atherosclerotic
介入
Coronary intervention(DEVICE)
Optimal Medical treatment(DRUG)
依頼者(Sponsor)
Seung-jung Park(OTHER)
実施施設 (1)
京都大学医学部附属病院
Kyoto, Japan